Effect of Low-Magnitude, High Frequency Vibration Treatment on Femoral Shaft Fracture Healing

Fracture, Closed, Comminuted, Healing Clinical Trial

Official title:

The Efficacy of Low-Magnitude, High Frequency Vibration Treatment on Accelerating the Healing of Femoral Shaft Fracture - A Prospective Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386749
• Other study ID #: 470410
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 22, 2011
• Last updated: July 27, 2015
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of HealthHong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Diaphyseal long bone fractures are usually associated with high energy trauma in which femoral shaft fracture is one common fracture in young age group. Surgery is usually needed for the diaphyseal lone bone fractures and the painful conditions always hinder weight bearing which is important for fracture healing and functional recovery. Fracture healing in cortical bone is less predictable than trabecular bone because they are less active and blood supply is more critical. Therefore accelerating fracture healing and rehabilitation of long bone fracture will absolutely bring significant economic benefit to the society in term of hospitalization and sick leave cost.

Low-magnitude, high-frequency vibration (LMHFV) treatment can provide systemic mechanical stimulation and is reported with multiple effects on musculoskeletal tissues. LMHFV can enhance the blood circulation and osteogenic effect in normal subjects and animals. Our previous clinical study also indicated that LMHFV could enhance the balancing ability and muscular function in normal post-menopausal women after treating whole-body vibration. For the fracture healing effect, an acceleration of healing by inducing callus formation and maturation in rat model was also reported in our previous studies.

In this study a total of 50 unilateral closed femoral shaft fracture patients of either gender aged 20-40 years old will be recruited and they will be randomized to either control and vibration group. The vibration group will be treated with LMHFV for 6 months. The findings of this study will provide very useful scientific data to support the application of LMHFV for fracture healing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• male or non-pregnant female aged 20-40 years old

• patient with unilateral femoral shaft fracture

• Fractures fixed with titanium intramedullary nail

• patient able to comply with study protocol including follow evaluation

Exclusion Criteria:

• open fracture

• bilateral fracture

• patient with multiple system injuries

• fracture gap > 10mm

• pathologic fracture

• pregnant women

• history of medication or disease affecting bone metabolism such as hypo- or hyperparathyroidism and hypo-, hyperthyroidism

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fracture, Closed, Comminuted, Healing
• Fractures, Bone
• Fractures, Closed

Intervention

Procedure:
• vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team
Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week

Locations

Country	Name	City	State
China	Department of Orthopaedics and Traumatology , The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to radiologic healing	The healing time of fracture site among subjects is assessed by noting the time of appearance of the first bridging callus in x-ray film as well as the second bridging callus and the third bridging callus	1 year	No
Secondary	Functional outcomes	The subjects are needed to perform functional outcome measurement according to our established protocol, including quality of life, muscle strength, balancing ability, vertical jump performance. The result of the above assessments will be reported as a scoring to show the functional performance and mobility of subjects.	1 year	No